NCT04576078 Post-operative Analgesic Effect of Oral Nefopam
| NCT ID | NCT04576078 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Hospices Civils de Lyon |
| Condition | Postoperative Pain After a Total Knee Arthroplasty |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2021-06-29 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2021-06-29 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Primary knee arthroplasty by total prosthesis is a painful surgery, performed on patients with advanced gonarthrosis (stage III), thus already presenting hyperalgesia and hyperalgesia and allodynia. This terrain makes the risk of postoperative hyperalgesia but also of persistent postoperative risk of persistent post-surgical pain. Nefopam is a non-opioid centrally acting analgesic drug used as a part of multimodal analgesia. The opioid-sparing effect of nefopam is still controversial across various surgical procedures. In France nefopam is only available as a parenteral formulation; however it is often administered orally. There is currently no study addressing the efficacy of oral nefopam for the postoperative pain management including pain prevention. The investigators conduct a prospective, double-blinded randomized controlled study with the main objective to examine the effect of perioperative orally administered nefopam on postoperative pain after a total knee arthroplasty. Secondary objectives include the quantification of wound allodynia, analysis of adverse events, clinical outcomes, and a pharmacokinetic study of orally given nefopam (plasma and cerebrospinal fluid dosage).
Eligibility Criteria
Inclusion Criteria: * adult patients scheduled for a total knee arthroplasty under spinal anesthesia at the Hopital de la Croix Rousse, Hospice Civils de Lyon, France. * ASA (American Society of Anesthesiology) class between 1 et 3. * written informed consent Exclusion Criteria: * any contraindication for nefopam (known hypersensitivity, past medical history of seizures, urinary retention, benign prostate hyperplasia, angle glaucoma, ischemic cardiomyopathy waiting for revascularization, atrial fibrillation) * medical conditions known to influence the pharmacokinetics of nefopam (chronic kidney failure with Glomerular Filtration Rate (GFR) \<30mL/min/1,73m2, liver failure, current treatment with rifampicin, carbamazepine, azoles fungicides, macrolides) * current treatment with benzodiazepines, anxiolytics, antidepressants, histamine H1 antagonists, neuroleptics, baclofen, thalidomide, barbiturates * medical history of gastric or esophageal surgery. * phenylketonuria * pregnancy or breastfeeding * past use of oral nefopam
Contact & Investigator
Frederic AUBRUN, MD/PHD
PRINCIPAL INVESTIGATOR
Département d'Anesthésie Réanimation, Hopital de la Croix Rousse
Frequently Asked Questions
Who can join the NCT04576078 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Postoperative Pain After a Total Knee Arthroplasty. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04576078 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04576078 currently recruiting?
Yes, NCT04576078 is actively recruiting participants. Contact the research team at Frederic.aubrun@chu-lyon.fr for enrollment information.
Where is the NCT04576078 trial being conducted?
This trial is being conducted at Lyon, France.
Who is sponsoring the NCT04576078 clinical trial?
NCT04576078 is sponsored by Hospices Civils de Lyon. The principal investigator is Frederic AUBRUN, MD/PHD at Département d'Anesthésie Réanimation, Hopital de la Croix Rousse. The trial plans to enroll 50 participants.